E&S Healthcare, Clinical Results of Blood-Based Breast Cancer In Vitro Diagnostic Medical Device Published in International Journal

World's First Blood-Based Breast Cancer Detection Kit 'DxMe BC Kit'
Measures Thioredoxin1 Levels... Sensitivity 97.17%, Specificity 94.15%

[Asia Economy Reporter Lee Gwan-ju] E&S Healthcare announced on the 6th that the clinical results and performance of the blood-based breast cancer in vitro diagnostic medical device 'DxMe BC Kit' have been published in the international cancer specialty journal 'BMC (BioMed Central) Cancer.'

The DxMe BC Kit developed by E&S Healthcare is the world's first blood-based breast cancer in vitro diagnostic medical device that can detect breast cancer using blood.

Through years of research, E&S Healthcare discovered the thioredoxin 1 (Trx1) protein applicable to breast cancer diagnosis. Thioredoxin 1 is a protein that balances redox activity within cells and is characterized by increased levels when malignant tumors occur in tissues and cells. Based on this research, E&S Healthcare developed an in vitro diagnostic medical device (IVD) that measures the level of thioredoxin 1 in blood and disclosed clinical research results evaluating and exploring the diagnostic performance for breast cancer through a paper.

The published paper analyzed the levels of thioredoxin 1 in the blood of normal women, breast cancer patients, and patients with other cancers using the DxMe BC Kit. The performance for detecting breast cancer showed a sensitivity of 97.17% and specificity of 94.15%, with the same accuracy observed in early-stage breast cancer cases (stage 0 and stage 1). The company also explained that high accuracy was demonstrated in benign tumors as well as other types of female cancers.

An E&S Healthcare official stated, “Breast cancer is one of the diseases that can be completely cured if diagnosed early and treated appropriately, but there have been difficulties in diagnosis due to the complexity of existing tests, radiation exposure, and dense breasts. The DxMe BC Kit will be a top-performing breast cancer in vitro diagnostic medical device that compensates for the shortcomings of existing tests and enhances diagnostic convenience and efficiency.”

The DxMe BC Kit completed the domestic product approval application with the Ministry of Food and Drug Safety in January. Internationally, it has obtained approval from regulatory authorities in Malaysia and Serbia, and is currently preparing for 510(k) approval to enter the U.S. market.

This content was produced with the assistance of AI translation services.